Efficacy of Pioglitazone on Bone Metabolism in Postmenopausal Women With Impaired Fasting Glucose.
A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Pioglitazone Compared to Placebo on Bone Metabolism in Impaired Fasting Glucose, Postmenopausal Women for One Year of Treatment
2 other identifiers
interventional
156
1 country
34
Brief Summary
The purpose of this study is to evaluate the effect of pioglitazone on bone metabolism in postmenopausal women with impaired fasting glucose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2008
Typical duration for phase_4
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 27, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
February 3, 2012
CompletedFebruary 3, 2012
January 1, 2012
2.7 years
June 27, 2008
January 3, 2012
January 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA)
The change in bone mineral density in the total proximal femur at month 12 relative to baseline. DXA is a means of measuring BMD through x-ray.
Baseline and Month 12.
Secondary Outcomes (1)
Percent Change From Month 12 to Month 18 in Bone Mineral Density in the Total Proximal Femur by DXA
Month 12 and Month 18.
Other Outcomes (3)
Change in Fasting Plasma Glucose (FPG)
Baseline and Month 12; Month 12 and Month 18.
Number of Participants Who Converted to Type 2 Diabetes Mellitus (T2DM)
Up to 18 months.
Number of Participants With Fracture
Up to 18 months.
Study Arms (2)
Pioglitazone
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
Eligibility Criteria
You may qualify if:
- Is female and has not experienced menses for at least 5 years.
- Has a Fasting Plasma Glucose level greater than or equal to 100 and less than 126 mg/dL or a 2-hour post-oral glucose tolerance test greater than or equal to 140 and less than or equal to 199 mg/dL at Screening.
- Has a body mass index greater than or equal to 16 and less than or equal to 40 kg/m2 and weighs less than 300 pounds (approximately 136 kilograms).
- Agrees to take daily supplements of Vitamin D (a minimum of 800 IU daily) and calcium (a minimum of 1000 mg daily) during the treatment and wash-out periods.
- Has clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis \[fasted for at least 8 hours\]) within the reference range for the testing laboratory unless the results are deemed not clinically significant by the investigator or sponsor.
- Is in good health as determined by the physician (ie, via medical history and physical examination) at Screening.
You may not qualify if:
- Has a fasting triglyceride level greater than 500 mg/dL.
- Has a hemoglobinopathy causing anemia or interfering with glycosylated hemoglobin assays.
- Has an alanine transaminase level greater than or equal to 2.5 times the upper limit of normal, active liver disease or jaundice.
- Has Vitamin D (25-OH-D) less than 20 ng/mL.
- Has Baseline Bone Mineral Density defined as a T-score less than -2.0 at the total hip, spine, or femoral neck based on Caucasian reference values.
- Has unexplained microscopic or macroscopic hematuria confirmed by repeat testing.
- Has any of the following disorders:
- Rheumatoid Arthritis
- Thyroid (uncontrolled on thyroid replacement therapy), parathyroid, pituitary, nutritional, inflammatory, gastrointestinal, autoimmune, or renal or other disease known to affect bone metabolism.
- A personal history of kidney stones.
- Has a clinical history after age 45 of wrist, hip, or leg fractures.
- Has a history of more than 1 asymptomatic vertebral deformity or any vertebral deformity attributed to osteoporosis.
- Has a known history of drug abuse (defined as illicit drug use) or a known history of alcohol abuse within 2 years of Screening.
- Has signs and/or symptoms of heart failure.
- Is currently participating in another investigational study or has participated in an investigational study within the past 30 days or 5 half lives of the investigational product, whichever is longer.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (34)
Unknown Facility
Greenbrae, California, United States
Unknown Facility
Los Banos, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
West Hills, California, United States
Unknown Facility
Lakewood, Colorado, United States
Unknown Facility
Longmont, Colorado, United States
Unknown Facility
Boynton Beach, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Jupiter, Florida, United States
Unknown Facility
Dunwoody, Georgia, United States
Unknown Facility
Gainesville, Georgia, United States
Unknown Facility
Honolulu, Hawaii, United States
Unknown Facility
Idaho Falls, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Iowa City, Iowa, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Metarie, Louisiana, United States
Unknown Facility
Scarborough, Maine, United States
Unknown Facility
Bethesda, Maryland, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Mineola, New York, United States
Unknown Facility
West Haverstraw, New York, United States
Unknown Facility
Pinehurst, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Aiken, South Carolina, United States
Unknown Facility
Greenville, South Carolina, United States
Unknown Facility
Brentwood, Tennessee, United States
Unknown Facility
Denton, Texas, United States
Unknown Facility
Houston, Texas, United States
Related Publications (2)
Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
PMID: 33210751DERIVEDBone HG, Lindsay R, McClung MR, Perez AT, Raanan MG, Spanheimer RG. Effects of pioglitazone on bone in postmenopausal women with impaired fasting glucose or impaired glucose tolerance: a randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2013 Dec;98(12):4691-701. doi: 10.1210/jc.2012-4096. Epub 2013 Sep 20.
PMID: 24057294DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY DIRECTOR
VP Clinical Science Strategy
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2008
First Posted
July 2, 2008
Study Start
May 1, 2008
Primary Completion
January 1, 2011
Study Completion
February 1, 2011
Last Updated
February 3, 2012
Results First Posted
February 3, 2012
Record last verified: 2012-01